Event Notification Report for May 27, 2024
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
05/26/2024 - 05/27/2024
Agreement State
Event Number: 57165
Rep Org: SC Dept of Health & Env Control
Licensee: Medical University - South Carolina
Region: 1
City: Charleston State: SC
County:
License #: SC-RML-081
Agreement: Y
Docket:
NRC Notified By: Adam Gause
HQ OPS Officer: Adam Koziol
Licensee: Medical University - South Carolina
Region: 1
City: Charleston State: SC
County:
License #: SC-RML-081
Agreement: Y
Docket:
NRC Notified By: Adam Gause
HQ OPS Officer: Adam Koziol
Notification Date: 06/06/2024
Notification Time: 08:25 [ET]
Event Date: 05/27/2024
Event Time: 00:00 [EDT]
Last Update Date: 08/13/2024
Notification Time: 08:25 [ET]
Event Date: 05/27/2024
Event Time: 00:00 [EDT]
Last Update Date: 08/13/2024
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
10 CFR Section:
Agreement State
Person (Organization):
Bickett, Carey (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
Bickett, Carey (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
EN Revision Imported Date: 8/14/2024
EN Revision Text: AGREEMENT STATE REPORT - BRACHYTHERAPY MISADMINISTRATION
The following information was provided by the South Carolina Department of Health and Environmental Control via phone and email:
"The South Carolina Department of Health and Environmental Control was notified on June 5, 2024, at 1130 EDT via telephone that a medical event had occurred at Medical University Hospital Authority d/b/a Medical University of South Carolina (licensee). The licensee reported that a patient had undergone a manual brachytherapy procedure (Gammatile Implantation) resulting in the implantation of forty (40) Cs-131 seeds in the patient's brain on May 16, 2024. The licensee reported that the patient had been released and then returned on May 27, 2024, due to medical complications. Seven (7) of the forty (40) Cs-131 seeds were removed from the patient on May 27, 2024, and the remaining thirty three (33) seeds were removed from the patient on May 30, 2024. The licensee is reporting that the total source strength administered differed by 20 percent or more from the total source strength documented in the post-implantation portion of the written directive."
SC Event Number: 240003
* * * UPDATE ON 6/7/24 AT 0812 EDT FROM ADAM GAUSE TO JOSUE RAMIREZ * * *
The following information was provided by the South Carolina Department of Health and Environmental Control via email:
"For the medical event, the licensee is reporting that the total source strength documented in the post-implantation portion of the written directive is 5.54 millicuries per seed, and 221.6 millicuries total (forty seeds implanted). At the conclusion of the initial procedure on May 16, 2024, the licensee is reporting that all seeds as documented in the post-implantation portion of the written directive were administered. As of May 30, 2024, all seeds had been removed from the patient due to medical complications."
Notified R1DO (Bickett), NMSS Events Notification (email).
* * * UPDATE ON 8/13/24 AT 0901 EDT FROM ADAM GAUSE TO TENISHA MEADOWS * * *
The following information was provided by the South Carolina Department of Health and Environmental Control via email:
On June 20, 2024, the licensee submitted a 15-day written report regarding the medical event. Department inspectors conducted an on-site visit between July 24 and July 31, 2024. Interviews with the licensee's representatives were consistent with the details outlined in the written report. The licensee has provided additional training to neurosurgery department staff. The investigation is considered closed.
Notified R1DO (Ford), NMSS Events Notification (email)
A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
EN Revision Text: AGREEMENT STATE REPORT - BRACHYTHERAPY MISADMINISTRATION
The following information was provided by the South Carolina Department of Health and Environmental Control via phone and email:
"The South Carolina Department of Health and Environmental Control was notified on June 5, 2024, at 1130 EDT via telephone that a medical event had occurred at Medical University Hospital Authority d/b/a Medical University of South Carolina (licensee). The licensee reported that a patient had undergone a manual brachytherapy procedure (Gammatile Implantation) resulting in the implantation of forty (40) Cs-131 seeds in the patient's brain on May 16, 2024. The licensee reported that the patient had been released and then returned on May 27, 2024, due to medical complications. Seven (7) of the forty (40) Cs-131 seeds were removed from the patient on May 27, 2024, and the remaining thirty three (33) seeds were removed from the patient on May 30, 2024. The licensee is reporting that the total source strength administered differed by 20 percent or more from the total source strength documented in the post-implantation portion of the written directive."
SC Event Number: 240003
* * * UPDATE ON 6/7/24 AT 0812 EDT FROM ADAM GAUSE TO JOSUE RAMIREZ * * *
The following information was provided by the South Carolina Department of Health and Environmental Control via email:
"For the medical event, the licensee is reporting that the total source strength documented in the post-implantation portion of the written directive is 5.54 millicuries per seed, and 221.6 millicuries total (forty seeds implanted). At the conclusion of the initial procedure on May 16, 2024, the licensee is reporting that all seeds as documented in the post-implantation portion of the written directive were administered. As of May 30, 2024, all seeds had been removed from the patient due to medical complications."
Notified R1DO (Bickett), NMSS Events Notification (email).
* * * UPDATE ON 8/13/24 AT 0901 EDT FROM ADAM GAUSE TO TENISHA MEADOWS * * *
The following information was provided by the South Carolina Department of Health and Environmental Control via email:
On June 20, 2024, the licensee submitted a 15-day written report regarding the medical event. Department inspectors conducted an on-site visit between July 24 and July 31, 2024. Interviews with the licensee's representatives were consistent with the details outlined in the written report. The licensee has provided additional training to neurosurgery department staff. The investigation is considered closed.
Notified R1DO (Ford), NMSS Events Notification (email)
A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
Agreement State
Event Number: 57166
Rep Org: SC Dept of Health & Env Control
Licensee: Medical University - South Carolina
Region: 1
City: Charleston State: SC
County:
License #: SC-RML-081
Agreement: Y
Docket:
NRC Notified By: Adam Gause
HQ OPS Officer: Adam Koziol
Licensee: Medical University - South Carolina
Region: 1
City: Charleston State: SC
County:
License #: SC-RML-081
Agreement: Y
Docket:
NRC Notified By: Adam Gause
HQ OPS Officer: Adam Koziol
Notification Date: 06/06/2024
Notification Time: 08:25 [ET]
Event Date: 05/27/2024
Event Time: 00:00 [EDT]
Last Update Date: 08/13/2024
Notification Time: 08:25 [ET]
Event Date: 05/27/2024
Event Time: 00:00 [EDT]
Last Update Date: 08/13/2024
Emergency Class: Non Emergency
10 CFR Section:
Agreement State
10 CFR Section:
Agreement State
Person (Organization):
Bickett, Carey (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
ILTAB, (EMAIL) (EMAIL)
Bickett, Carey (R1DO)
NMSS_EVENTS_NOTIFICATION (EMAIL)
ILTAB, (EMAIL) (EMAIL)
EN Revision Imported Date: 8/14/2024
EN Revision Text: AGREEMENT STATE REPORT - LOST BRACHYTHERAPY SEEDS
The following information was provided by the South Carolina Department of Health and Environmental Control via phone and email:
"The South Carolina Department of Health and Environmental Control was notified on June 5, 2024, at 1130 EDT via telephone that a medical event had occurred at Medical University Hospital Authority d/b/a Medical University of South Carolina (licensee). The licensee reported that a patient had undergone a manual brachytherapy procedure (Gammatile Implantation) resulting in the implantation of forty (40) Cs-131 seeds in the patient's brain on May 16, 2024. The licensee reported that the patient had been released and then returned on May 27, 2024, due to medical complications. Seven (7) of the forty (40) Cs-131 seeds were removed from the patient on May 27, 2024, and the remaining thirty three (33) seeds were removed from the patient on May 30, 2024.
"The licensee is reporting that on May 27, 2024, the seven (7) Cs-131 seeds that were removed from the patient are lost or missing. The other thirty three (33) seeds are accounted for."
SC Event Number: 240003
The following additional information was obtained from the licensee in accordance with Headquarters Operations Officers Report Guidance:
The exact source strength of the lost seeds was not provided, however, the licensee reported that the quantity was greater than 10 times but less than 1000 times the 10CFR20 Appendix C value for Cs-131.
* * * UPDATE ON 6/7/24 AT 0812 EDT FROM ADAM GAUSE TO JOSUE RAMIREZ * * *
The following information was provided by the South Carolina Department of Health and Environmental Control via email:
"For the seven (7) Cs-131 seeds that were lost on May 27, 2024, the licensee is reporting the estimated activity at the time of removal and loss was approximately 2.5 millicuries per seed and approximately 17.5 millicuries total."
Notified R1DO (Bickett), NMSS Events Notification (email), ILTAB (email).
* * * UPDATE ON 8/13/24 AT 0901 EDT FROM ADAM GAUSE TO TENISHA MEADOWS * * *
The following information was provided by the South Carolina Department of Health and Environmental Control via email:
On June 20, 2024, the licensee submitted a 30-day written report regarding the loss of seven (7) Cs-131 seeds. Department inspectors conducted an on-site visit between July 24 and July 31, 2024. Interviews with the licensee's representatives were consistent with the details outlined in the written report. The licensee has provided additional training to neurosurgery department staff. The investigation is considered closed.
Notified R1DO (Ford), NMSS Events Notification (email), ILTAB (email).
THIS MATERIAL EVENT CONTAINS A 'Less than Cat 3' LEVEL OF RADIOACTIVE MATERIAL
Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf
EN Revision Text: AGREEMENT STATE REPORT - LOST BRACHYTHERAPY SEEDS
The following information was provided by the South Carolina Department of Health and Environmental Control via phone and email:
"The South Carolina Department of Health and Environmental Control was notified on June 5, 2024, at 1130 EDT via telephone that a medical event had occurred at Medical University Hospital Authority d/b/a Medical University of South Carolina (licensee). The licensee reported that a patient had undergone a manual brachytherapy procedure (Gammatile Implantation) resulting in the implantation of forty (40) Cs-131 seeds in the patient's brain on May 16, 2024. The licensee reported that the patient had been released and then returned on May 27, 2024, due to medical complications. Seven (7) of the forty (40) Cs-131 seeds were removed from the patient on May 27, 2024, and the remaining thirty three (33) seeds were removed from the patient on May 30, 2024.
"The licensee is reporting that on May 27, 2024, the seven (7) Cs-131 seeds that were removed from the patient are lost or missing. The other thirty three (33) seeds are accounted for."
SC Event Number: 240003
The following additional information was obtained from the licensee in accordance with Headquarters Operations Officers Report Guidance:
The exact source strength of the lost seeds was not provided, however, the licensee reported that the quantity was greater than 10 times but less than 1000 times the 10CFR20 Appendix C value for Cs-131.
* * * UPDATE ON 6/7/24 AT 0812 EDT FROM ADAM GAUSE TO JOSUE RAMIREZ * * *
The following information was provided by the South Carolina Department of Health and Environmental Control via email:
"For the seven (7) Cs-131 seeds that were lost on May 27, 2024, the licensee is reporting the estimated activity at the time of removal and loss was approximately 2.5 millicuries per seed and approximately 17.5 millicuries total."
Notified R1DO (Bickett), NMSS Events Notification (email), ILTAB (email).
* * * UPDATE ON 8/13/24 AT 0901 EDT FROM ADAM GAUSE TO TENISHA MEADOWS * * *
The following information was provided by the South Carolina Department of Health and Environmental Control via email:
On June 20, 2024, the licensee submitted a 30-day written report regarding the loss of seven (7) Cs-131 seeds. Department inspectors conducted an on-site visit between July 24 and July 31, 2024. Interviews with the licensee's representatives were consistent with the details outlined in the written report. The licensee has provided additional training to neurosurgery department staff. The investigation is considered closed.
Notified R1DO (Ford), NMSS Events Notification (email), ILTAB (email).
THIS MATERIAL EVENT CONTAINS A 'Less than Cat 3' LEVEL OF RADIOACTIVE MATERIAL
Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf